CN1432807A - Connector for electrochemical sensor - Google Patents

Connector for electrochemical sensor Download PDF

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Publication number
CN1432807A
CN1432807A CN03100219A CN03100219A CN1432807A CN 1432807 A CN1432807 A CN 1432807A CN 03100219 A CN03100219 A CN 03100219A CN 03100219 A CN03100219 A CN 03100219A CN 1432807 A CN1432807 A CN 1432807A
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conductive coating
edge
dielectric base
dielectric
isolation layer
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CN100351627C (en
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A·M·霍格斯
G·钱伯斯
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LifeScan Inc
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LifeScan Inc
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3273Devices therefor, e.g. test element readers, circuitry
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S439/00Electrical connectors
    • Y10S439/909Medical use or attached to human body

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Hematology (AREA)
  • General Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Connection Of Batteries Or Terminals (AREA)
  • Primary Cells (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Electrolytic Production Of Non-Metals, Compounds, Apparatuses Therefor (AREA)

Abstract

The present invention relates to electrochemical cells including a connector which mates with a connection device to provide electrical connection to meter circuitry.

Description

The electrochemical sensor connector
Technical field
The present invention relates to comprise the electrochemical sensor of connector, this connector matches with the meter coupling arrangement, to provide and being electrically connected of meter circuit.
Background technology
The small electrical chemical sensor is useful in the application such as chemical measurement, and wherein the electrode of bar element is connected with electronic equipment.This electronic equipment is referred to as meter usually, measures the electroresponse of bar element for sample, and can be bar element and provide electric power to carry out test.In order to realize these functions, the bar element electrode must be electrically connected with the meter circuit.This electrical connection can realize that this coupling arrangement matches with the zone on the bar element by the coupling arrangement on the meter, thereby can be electrically connected with the electrode of electrochemical sensor.
In the structure as disclosed electrochemical sensor among WO98/43073, U.S.5437999, EP0964059A2, the WO00/20626, upper/lower electrode is placed mutually face-to-face, and there is an electricity isolated layer centre.The electrode of this configuration typically is placed in the independent substrate, and this substrate is to be assembled in the process of making electrochemical sensor.When forming the bar element electrode and be connected to the part of meter circuit by it, this structure has difficulties on making, because it is different from all at grade syndetons of all common bonding pads.
The problem of bonding pad has solved in various manners on the Different Plane.In WO98/43073, a kind of method and apparatus is disclosed, wherein in an electrode layer and insulation course, to construct a fracture, thereby expose following electrode layer, it can be used as the bonding pad.In U.S.5437999 and WO00/20626, a kind of method and apparatus is disclosed, wherein on an electrode layer, constructed a baffle plate, therefore, in another electrode layer, form corresponding fracture to expose suitable bonding pad.In this structure, thereby insulation course is prescinded not and the bonding pad interference.
In EP0964059A2, insulation course is prescinded, and forms a hole in the substrate on upper strata, thereby exposes the bonding pad of formed cavity bottom.Can the filled conductive material in the cavity, make a contact at the top of the cavity that fills up with conductive material, so just the bonding pad is taken on the plane.
The defective of these structures is, when being installed to sensor layer on the equipment, needs to provide the parts of mutual location on an above sensor layer.Will when process units, produce difficulty like this, and limit adaptable production technology.Particularly, based on the consideration of cost and output, need to make the bar element of continuous net sheet form usually.When using continuous net sheet, before lamination step, the net sheet that often is difficult to realize reliably being positioned at the duplicate components on the different layers is (down-web) location vertically.Realize that if possible this needs expensive control system usually and has relative destructive manufacturing process.
Summary of the invention
We need be applicable to the electrochemical sensor connector that links to each other with the comparative electrode electrochemical sensor, and the method for making this connector, and the method need be in the net sheet longitudinal register step before the lamination electrode layer.Following preferred embodiment provides this electrochemical sensor connector and preparation method thereof.
In first embodiment, a kind of electrochemical sensor is provided, adopt between this electrochemical sensor and the meter and be electrically connected, this sensor comprises first dielectric base with first conductive coating, second dielectric base with second conductive coating, and be positioned between the two dielectric isolation layer, two conductive coatings are provided with in spaced relation mutually face-to-face, wherein, edge with first dielectric base of first conductive coating has extended beyond the edge of second dielectric base with second conductive coating, and surpass the edge of dielectric isolation layer, wherein, the edge with second dielectric base of second conductive coating has extended beyond the edge of dielectric isolation layer.
In aspect of first embodiment, extend beyond the part at dielectric isolation layer edge in first dielectric base with first conductive coating, first dielectric base with first conductive coating comprises an aperture, make the second electrode lay expose a zone, thereby provide a surface by aperture, with structure and being electrically connected of meter.
In aspect of first embodiment, sensor further comprises a superinsulation separation layer, and this additional isolation layer is between first conductive coating and second conductive coating, and wherein dielectric isolation layer and additional isolation layer are positioned at the opposite side of aperture.
In second embodiment, a kind of electrochemical sensor is provided, adopt between this electrochemical sensor and the meter and be electrically connected, this sensor comprises first dielectric base with first conductive coating, second dielectric base with second conductive coating, and be positioned between the two dielectric isolation layer, two conductive coatings are provided with in spaced relation mutually face-to-face, wherein, edge with first dielectric base of first conductive coating has extended beyond the edge of second dielectric base with second conductive coating, and the edge that surpasses dielectric isolation layer, wherein, first dielectric base and dielectric isolation layer with first conductive coating comprise an aperture, make the second electrode lay expose a zone, thereby provide a surface by aperture, to form and being electrically connected of meter.
In the 3rd embodiment, a kind of electrochemical sensor is provided, this electrochemical sensor be applicable to meter between adopt and be electrically connected, this sensor comprises first dielectric base with first conductive coating, second dielectric base with second conductive coating, and be positioned between the two dielectric isolation layer, two conductive coatings are provided with mutually face-to-face with the relation of isolating, wherein, first dielectric base that a part has first conductive coating has extended beyond the edge of second dielectric base with second conductive coating, and the edge that surpasses dielectric isolation layer, wherein, first dielectric base and a part of dielectric isolation layer that a part has first conductive coating are removed, thereby form a groove, this groove is adjacent with the marginal position of edge of second dielectric base with second conductive coating and dielectric isolation layer, makes the second electrode lay expose a zone, thereby provide a surface, with structure and being electrically connected of meter.
In the 4th embodiment, the method that structure is electrically connected between electrochemical sensor and meter is provided, the method may further comprise the steps: a kind of electrochemical sensor is provided, this electrochemical sensor comprises first dielectric base with first conductive coating, second dielectric base with second conductive coating, and be positioned between the two dielectric isolation layer, two conductive coatings are provided with in spaced relation mutually face-to-face, wherein, edge with first dielectric base of first conductive coating has extended beyond the edge of second dielectric base with second conductive coating, and the edge that surpasses dielectric isolation layer, wherein, the edge with second dielectric base of second conductive coating has extended beyond the edge of dielectric isolation layer; A meter is provided, and this meter comprises a voussoir, and this voussoir comprises that one is gone up wedge shape conductive surface and a following wedge shape conductive surface, and two conductive surfaces are electrically connected with meter; The part of electrochemical sensor is inserted meter, like this, voussoir with regard to be inserted into a part that extends beyond the dielectric isolation layer edge have first conductive coating first dielectric base and a part have between second dielectric base of second conductive coating, so just constituted the electrical connection between first conductive coating and the following wedge shape conductive surface, and the electrical connection between second conductive coating and the last wedge shape conductive surface.
In aspect of the 4th embodiment, meter further comprises a fulcrum, and wherein voussoir can rotate on fulcrum.
The accompanying drawing summary
Fig. 1 a and 1b represent the schematic diagram of electrochemical sensor, and wherein unit 2 departs from the edge of units corresponding 1, thereby expose the conductive coating on the unit 1.Fig. 1 a is a top view, and Fig. 1 b is a cross-sectional view.
Fig. 2 a and 2b represent the schematic diagram of electrochemical sensor, wherein excavate a hole in unit 1, to expose the conductive coating on the unit 2 that is used to be electrically connected.Fig. 2 a is a top view, and Fig. 2 b is a cross-sectional view.
Fig. 3 a and 3b representation class are similar to the schematic diagram of the electrochemical sensor of sensor among Fig. 2, except the extention of unit 3 has been inserted between unit 1 and 2.Fig. 3 a is a top view, and Fig. 3 b is a cross-sectional view.
Fig. 4 a and 4b represent the schematic diagram of electrochemical sensor, wherein form a groove in unit 1, and this groove provides the passage in the conductive coating zone on the unit 2.Fig. 4 a is a top view, and Fig. 4 b is a cross-sectional view.
Fig. 5 a and 5b representation class are similar to the schematic diagram of the electrochemical sensor of sensor among Fig. 2, are positioned at the top of the unit 4 of unit 1 except unit 3.Fig. 5 a is a top view, and Fig. 5 b is a cross-sectional view.
Fig. 6 a and 6b representation class are similar to the schematic diagram of the electrochemical sensor of sensor among Fig. 4, except the edge of unit 3 at least near the edge of unit 1.Fig. 6 a is a top view, and Fig. 6 b is a cross-sectional view.
Fig. 7 is a side view, has shown cutting apart of unit 1 and unit 2 in scope connector, thereby has made it enter the ligule coupling arrangement.
Fig. 8 is an end-view, has shown cutting apart of unit 1 and unit 2 in scope connector, thereby has made it enter the ligule coupling arrangement.
Fig. 9 is the graphic extension that part is inserted the bar (strip) of external circuit connector.
Figure 10 is the graphic extension of inserting the bar of external circuit connector fully.
Figure 11 represents the side view of external circuit connector 100.
Figure 12 is the graphic extension that part is inserted the bar of the external circuit connector 100 shown in Figure 11.
Figure 13 is the graphic extension of inserting the bar of the external circuit connector 100 shown in Figure 11 fully.
Preferred embodiment describes in detail
Following description and example describe the preferred embodiments of the present invention in detail.It will be understood by those skilled in the art in and comprise many variants and remodeling in the scope of the present invention.Therefore, the description of preferred embodiment can't limit the scope of the invention.
Preferred embodiment relates to the apparatus and method of structure electrode bonding pad in having the electrochemical sensor of comparative electrode.These apparatus and method did not need to locate the parts that are positioned on the different layers before the lamination sensor layer.Particularly, apparatus and method provided by the invention during the continuous net sheet of this device of lamination, do not need the net sheet longitudinal register of duplicate devices in manufacturing process.Preferred embodiment can use in conjunction with any suitable manufacturing process, and for example, the discontinuous part quilt of sensor layer is the process of lamination together, thus and the process that helps reducing location requirement reduction making complicacy.
In another embodiment, provide a kind of port preferred cell that is applicable in the meter device that is used with disclosed strip connector.
The essential characteristic of the electrochemical sensor shown in Fig. 1-6 is: the edge of at least one electrode layer (being referred to as upper electrode layer here) departs from another electrode of opposite layer (being referred to as lower electrode layer here) at least, make a zone of lower electrode layer extend beyond the edge of upper electrode layer, thereby expose a zone that is applicable to the lower electrode layer that connects the meter circuit.
Fig. 1 to 6 has shown the diagrammatic sketch of the various preferred embodiments of electrochemical sensor connector.Fig. 1 a, 2a, 3a, 4a, 5a and 6a are the net sheet of various each assembly layer of embodiment or the top view of curtate, have shown repeated characteristic.Fig. 1 b, 2b, 3b, 4b, 5b and 6b are corresponding cross-sectional views.
In Fig. 1 to 6, unit 1 is a lower electrode layer.This layer comprises the electrical insulating substrate with conductive coating, and coating is positioned at the end face of this substrate, and wherein, conductive coating electrically contacts with first electrode of electrochemical sensor at least.
Unit 2 is upper electrode layers.This layer comprises the electrical insulating substrate with conductive coating, and coating is positioned at the bottom surface of this substrate, and wherein, conductive coating electrically contacts with second electrode of electrochemical sensor at least.
Unit 3 is to be used for the electric insulation layer of isolated location 1 and 2.In a preferred embodiment, the end face and the bottom surface of unit 3 have viscosity, are used for each layer of device is bonded together.In this preferred embodiment, unit 3 can comprise the substrate that scribbles bonding agent.Unit 3 can optionally include only a bonding coat.
Unit 4 is the fracture positions in the unit 1, and shown in Fig. 2 to 6, it is used for providing a passage, to expose the conductive coating district of 2 bottom surfaces, unit.
In Fig. 1, an edge of unit 2 departs from unit 1 respective edges, thereby the conductive coating that exposes on the unit 1 stretches out the district.In a preferred embodiment, the electrical insulating substrate material tongue that has conductive coating or thin layer in end face and bottom surface is inserted between unit 1 and 2, thereby and the meter circuit form and be electrically connected.
In Fig. 2, in unit 1, cut a through hole to expose the zone of the conductive coating on the unit 2 that is used to be electrically connected.Eliminated like this coupling arrangement has been inserted requirement between the sensor layer.
Device shown in Fig. 3 is similar to shown in Figure 2, except the extention of unit 3 is inserted between the unit 1 and 2.If in use, possibly unit 1 and 2 is incorporated into together, thereby when forming electrical short between the conductive coating on unit 1 and unit 2, this structure is desirable.
Among the embodiment shown in Figure 4, constructed a slit on unit 1, this slit has provided the passage in conductive coating district on the unit 2.
Fig. 5 illustrates the embodiment that is similar among Fig. 2.But, in this embodiment, above the unit 4 of the edge of unit 3 in unit 1.In order to realize the operability of this embodiment, in a preferred embodiment, before tectonic element 4, unit 1 and 2 must be assembled together by lamination or with them.
Fig. 6 illustrates the embodiment that is similar among Fig. 4.But, in this embodiment, the edge of close at least unit 1, the edge of unit 3.In this embodiment, be preferably, before tectonic element 4, unit 1 and 2 must be assembled together by lamination or with them.
In another embodiment, the method that is electrically connected with some above-mentioned coupling arrangements formations is disclosed.
For the electrochemical sensor of the preferred embodiment shown in Fig. 2 to 6, it is applicable to element the conductive coating on unit 1 and 2 is connected to external circuit, the circuit described in the common unsettled U.S. Patent application 09/399512 of application on September 20th, 1999.
For the embodiment shown in Fig. 1, need a different outer portion connecting structure.For this embodiment, we need separate unit 1 and unit 2 in the bonding pad, thereby are easy to insert the ligule coupling arrangement.According to this characteristics of this embodiment, when the strip connector was inserted the external circuit connector, unit 1 and unit 2 were separated, for example, and with blade shape or wedge shape protrusion or other tripping devices that is fit to.
Fig. 7 and 8 is respectively side view and end-view, and it has shown separating of unit, bonding pad 1 and unit 2, to insert the ligule coupling arrangement.Fig. 9 and 10 has shown that bar is by part and this embodiment that inserts the external circuit connector fully.
External circuit connector 10 shown in Fig. 7 to 10 comprises an inner chamber 18, and this inner chamber comprises the cavity 11 and 12 that can be respectively the unit 1 and the unit 2 of bar be inserted wherein.One or more wedge projections 17 are arranged on the sidewall of inner chamber 18, and when bar inserted inner chamber 18, this teat was used for separating bar unit 1 and 2.When bar inserted inner chamber 18, unit 1 at first struck the bottom surface of teat 17 and is depressed.In insert action, this action further separates unit 1 and unit 2, thereby reliably unit 2 is inserted cavitys 12.
Another wedge projection is outstanding from the back of inner chamber 18.On the surface 13 and 14 of this teat conductive layer is housed, wherein, these two conductive layers are electrically insulated from one another.These layers electrically contact with conductive coating on bar unit 1 and 2.Electrical lead or other strip conductors 15 and 16 are electrically connected to the conductive layer on the surface 13 and 14, are used for being connected with external circuit formation.One skilled in the art will appreciate that and to comprise the device of conductive layer 13 and 14 by structured surface, thereby make itself and teat 17 form an integral body.
Figure 11 to 13 shows second embodiment.Figure 11 is the side view of embodiment.Figure 12 and 13 is the side views that bar partially or completely inserted embodiment wherein respectively.
Figure 11 to 13 is depicted as external circuit connector 100, and this connector comprises an inner chamber 105, and this inner chamber comprises a voussoir 101 that can rotate around fulcrum 102 in inner chamber 105.This voussoir comprises the conductive surface 106 and 107 that is electrically connected on outside tie point 103 and 104.Voussoir 101 is subjected to gravity or spring stretching device (not shown) on its initial position effect is fixed, make voussoir the position as shown in figure 11.When bar inserts inner chamber 105, the bottom surface of the voussoir 101 behind the bottom electrode unit bump fulcrum 102.This action can rotation voussoir 101, makes the summit of voussoir 101 between the upper/lower electrode layer of bar.Then, when bar further inserted inner chamber 105, last voussoir surface 106 touched the conductive coating of bar unit.Thereby can realize being electrically connected of conductive coating and tie point 103 on the bar unit through conductive surface 106, equally, pass through conductive surface 107 and can realize being electrically connected of conductive coating and tie point 104 on the bottom electrode strip thing unit.
The advantage of embodiment shown in Figure 11 to 13 is that the summit of voussoir 101 can navigate to up and down between the bar electrode unit, to guarantee reliable connection automatically.
Electrochemical sensor
The electrochemical sensor connector of preferred embodiment is applicable to various electrochemical sensors.For example, connector can be used to connect the electrochemical sensor that is used as the ammeter sensor, is used for the detection and the quantification of analyte.
In this application, determine that the position of electrode makes that working electrode and counter electrode reaction and reaction product are isolated, or make the counter electrode reaction product be diffused on the working electrode that they react at this working electrode place.Last type electrochemical sensor is well known in the prior art, and back one type electrochemical sensor is discussed in US6179979 and US5942102.
The difference of these two kinds of electrode structures is the isolation situation, and counter electrode is placed on apart from working electrode position enough far away, makes in the sensor use, and the electrochemical reaction product on the counter electrode can not arrive working electrode.In fact, this structure can be typically realizes by working electrode and counter electrode are separated 1 mm distance at least.
In non-isolation structure, the position of working electrode and counter electrode is enough near, makes in the sensor use, and the electrochemical reaction product on the counter electrode can be diffused on the working electrode.Then, these reaction product react on working electrode, and obtaining ratio can getable higher electric current under the isolated electrode situation.In non-isolation structure, the working electrode reaction can be described as the coupling (couple) of counter electrode reaction.
The making of electrochemical sensor
In certain embodiments, the electrochemical sensor of preferred embodiment can be made of being similar among the U.S.5942102 disclosed method.
Those skilled in the art will appreciate that electrode layer and electricity isolate substrate and can independently as required select, for example, for the ease of making, in order to reduce material cost, or in order to reach other required features of sensor or manufacturing process.Equally, electrode layer can be applied to electric insulation layer with any suitable mode, for example, and only partly to cover the mode of substrate.
In a preferred embodiment, the available suitable adhesive of each layer in the sensor is bonding.Suitable adhesive comprises, for example, and heat activated adhesive, contact adhesive, thermal treatment bonding agent, chemical treatment bonding agent, hotmelt, hot-fluid bonding agent and similar bonding agent thereof.Contact adhesive preferably uses to be needed to simplify among some embodiment of manufacturing process therein.But in a further embodiment, the viscosity of contact adhesive can cause the bonding or product of tools bonding.In these embodiments, heat or chemical treatment bonding agent are normally preferred.Particularly preferably be the active and thermal treatment bonding agent of heat, it can be activated easily suitable time marquis.
In certain embodiments, can the advantageous applications hotmelt.Hotmelt is solvent-free thermoplastic, and it is a solid when room temperature, is applied to its bonding surface with melted form when being cooled to its fusing point when following.To surpass in the chemical treatment of melting range be effective to hotmelt various.Hotmelt can be form or any other suitable form of net sheet, non-woven material, weaving material, powder, solution.The polyester hot melting bonding agent can be preferred for some embodiment.This bonding agent (for example, can be from Middleton, the Bostik company of MA obtains) and be linear saturated polyester's heat fusing thing, its fusing point is from 65 ℃ to 220 ℃, and its state range is from fully noncrystal to highly crystalline in essence.Polyamide (nylon) hotmelt also can obtain from Bostik company, also can be preferred, comprise dimer acid and nylon type polyamide binder.Suitable hotmelt chemical substance comprises EVA, tygon and polypropylene.
What can select is, can some layer to be bonded together the advantageous applications lamination among other the embodiment at some.The lamination that is fit to is that the application number of 09/694106 application and application on October 20th, 2000 is to describe in 09/694120 the application at the application number of application on October 20th, 2000, and its exercise question is " LAMINATES OF ASYMMETRICMEMBRANES (lamination of asymmetric dividing plate) ".By each layer placed adjacent of lamination and heating, so just formed the joint between each layer.Also can exert pressure with the formation that helps to engage.Can preferably under the situation of heating and/or pressurization, can engage any two kinds of laminating methods that can form the material of joint.Preferably can between two kinds of suitable polymeric materials, form the lamination that engages.
Can be preferably as separation layer, comprise as the support of electrode layer or the resistance material that is fit to that is applied to other layers of sensor, for example, these mixtures of material and/or the composition of similar polyester, polystyrene, polycarbonate, polyolefin, polyethylene terephthalate, glass, pottery, and materials similar.The resistive bonding agent that is fit to use as isolation or supporting layer include but not limited to polyacrylate, polymethacrylate, polyurethane and sulfonated polyester.
Be applied to the chemicals in the sensor, as redox reagent, solvent, buffering agent, indifferent salt and other materials, can remain on sensor electrode or the inwall, can remain on the independent support in one or more sensors or self-support.If chemicals is remained on sensor electrode or the inwall, can utilize then that well-known application technology applies chemicals in this area, such as ink jet printing, serigraphy, lithography, ultrasonic spray, groove coating, intaglio printing and other similar techniques.The independent support that is fit to include but not limited to grid, non-woven sheets, fiberfill, macropore film and sintered powder.The chemicals that uses in the sensor can be distributed in to support and go up or be included in the support.
In a preferred embodiment, in the sensor and the preferred material that constitutes sensor be obeying the form of the needs of producing in batches, and sensor itself be designed to after the single test discardable.Discardable sensor is that production cost is low, only is used for single test, acceptable disposable sensor economically.Discardable sensor is the disposable sensor that can only be used for single test easily, that is, after single uses, may need to take such as clean and/or this sensor of step process of refitting reagent so that its can be suitable for reusing.
The acceptable economically meaning is in the context: for the user, the cost of the perceived value of test findings and the sensor of purchase and use identical or compare higher, the sensor purchasing price increases corresponding price markup by the cost of the sensor that offers the user and determines.Use for some, preferably have the sensor of low relatively material cost and simpler production process.For example, the electrode material of sensor can be cheap, carbon for example, and perhaps required total amount of material is enough few, makes preferably expensive material.Serigraphy carbon ink or silver are the methods that is applicable to the electrode of making relatively inexpensive material.But, use electrode material if desired such as platinum, palladium, gold or iridium, then method such as the sputtering method of material employing preferably or steam-spraying are preferred, because can obtain thin especially film like this.The base material that disposable sensor is used also is preferably cheap.The example of these cheap materials is such as the polymkeric substance of Polyvinylchloride, polyimide, polyester and art paper and cardboard.
The assembly method of sensor preferably is fit to the method for batch process.These methods are included in after the main installation step, go up at card (card) and make a plurality of sensors, then card are divided into wall scroll, and net sheet (web) making, and wherein sensor is divided into wall scroll subsequently producing on the net sheet continuously.The card method is best suited for when the space orientation of a plurality of parts of need making closely the time, and/or when preferably hard sensor base material.Net sheet method is best suited for net sheet longitudinal register when parts and requires not strict and can preferred flexible net sheet the time.
In certain embodiments, may need electrochemical sensor is disposable easily use, so that the user can not attempt to reuse sensor and may obtain coarse test findings.The disposable use of sensor may be stipulated in the instruction manual book subsidiary with sensor.More preferably, in some needs disposable embodiment, can make this sensor, make that using this sensor is difficulty or impossible more than once.For example, in first time process of the test, can realize above function with removing reagent or consuming compositions and methods, like this, sensor can lose efficacy when testing for the second time.Whether optionally, detect test signal and react with the reagent in the indication sensor and finish, for example, improper high initialize signal and test are interrupted.Another kind method comprises after sensor has been finished test for the first time, and a kind of device that is electrically connected in the sensor that disconnects is provided.
Electrode
The existence of analyte and/or total amount in the electrochemical sensor test sample, or indicate the existence of analyte in the sample and/or the material of total amount, in this preferred embodiment, at least one electrode in the sensor is a working electrode.When the level (for example in electric potential sensor) of the electromotive force of working electrode indication analyte, need second electrode as the reference electrode to be used to provide reference potential.
In ammeter sensor example, working electrode electric current indication analyte is the level of glucose for example, is preferably, and has an other electrode at least, its as counter electrode so that circuit is complete.This second electrode also can be used as reference electrode.Single electrode can optionally be carried out the function of reference electrode.
Any reagent or the material that exist in the material that is applicable to work, counting and reference electrode and the device are compatible.Chemical reaction can not take place in other materials in compatible material and the sensor basically.This suitable examples of material can include but not limited to, the potpourri of carbon, carbon and organic binder bond, platinum, palladium, graphite, indium oxide, tin oxide, indium oxide/tin oxide, gold, silver, iridium, and their potpourri.Can these materials be constituted electrode structure with any suitable method, for example, sputter, steam-spraying, serigraphy, heating power evaporation, intaglio printing, groove spraying or lithography.In a preferred embodiment, material is constructed electrode structure with the method for sputter or serigraphy.
The example of indefiniteness that preferably is used as the material of reference electrode comprises: metal/metal salt system, for example silver that contacts with silver chloride, silver bromide or silver iodide, and the mercury that contacts with mercuric chloride or mercuric sulfate.Metal can contact with proper metal salt then with any suitable method deposition.Suitable method comprises: for example, and electrolysis or chemical oxidation in suitable salt solusion.This metal/metal salt system system than single metal composition on the potentiometer measuring method provides better electromotive force control.In a preferred embodiment, in the ammeter sensor, the metal/metal salt electrode system is preferably as independent reference electrode.
Can adopt any suitable electrode separation.In certain embodiments, preferably the distance of spaced-apart electrodes is about 500 μ m, 400 μ m, 300 μ m, 200 μ m, 100 μ m, 50 μ m, 20 μ m, 10 μ m or still less.In other embodiment, preferably the distance of spaced-apart electrodes is about 500 μ m, 600 μ m, 700 μ m, 800 μ m, 900 μ m, 1mm or more.
Solvent
In certain embodiments, may in electrochemical sensor, comprise one or more solvents.The solvent that is fit to comprises: ionization and non-ionized detersive, proteinase and lipase.The ionization detersive that is fit to comprises, for example, and sodium dodecylsulphonate and cetyl trimethyl ammonium bromide.The example of the indefiniteness of proteinase comprises insulin, chymotrypsin, pepsin, papain, pronase e, the organized enzyme with extensive characteristic.The unionized surfactant that is suitable for comprises, for example, the ethoxylation octyl phenol, comprises the Rohm﹠amp from philadelphia, pa; The TRITON X that Haas obtains TMSeries.In a preferred embodiment, saponin, the plant glycosides that promptly bubbles in water is preferably as solvent.In a concrete preferred embodiment, the alkali metal salt of the deoxycholic acid that obtains from the Sigma Aldrich Pty company in New South Wales, Australia Hill city is preferably as solvent.
Reductant-oxidant
Electrochemical sensor also can comprise reductant-oxidant in a preferred embodiment.That uses in the electrochemical sensor is used for measuring the reductant-oxidant that the preferred reductant-oxidant of glucose in the blood comprises the degraded form of those oxidable enzymes, and this kind of enzyme is oxidizing glucose optionally.The example of the enzyme that is fit to include but not limited to glucose oxidase dehydrogenasa, the NAD that is attached to the PQQ of glucose dehydrogenase and is attached to glucose dehydrogenase.The example that is applicable to the reductant-oxidant of decomposition glucose include but not limited to, the salt of the ferricyanide, dichromate, vanadium oxide, permanganate and electroactive organic metal potpourri.The organic oxidation reductive agent also is fit to as antiphen indophenols and quinone.In a preferred embodiment, the reductant-oxidant of decomposition glucose is the ferricyanide.
Buffering agent
Buffering agent can be placed arbitrarily along reductant-oxidant in electrochemical sensor with dried forms.If the placement buffering agent, then the pH value that causes of the total amount of its existence should be: be fit to the oxidation potential of reductant-oxidant adjusted to and be fit to for example glucose of oxidation, rather than other do not need the value of the type that detects.Thereby buffering agent should have enough amounts remains on needed value substantially with the pH value of sample in the process of the test.The example of the buffering agent that is fit to comprises: the alkali metal salt of the alkali metal salt of phosphate, carbonate, mellitic acid, the alkali metal salt of citric acid and citraconic acid.In other various factorss, buffering agent should be selected according to required pH value.Select buffering agent that it can not reacted with reductant-oxidant.
Indifferent salt
The preferred in various embodiments indifferent salt that uses comprises: decompose the back and in analyzed sample, form ion, and not with sample in or comprise the salt that any reductant-oxidant in the sensor of sensor electrode or other materials react.The example of the indifferent salt that is fit to include but not limited to alkali metal chloride, nitrate, sulfate and phosphate.
Other materials in the sensor
Except reductant-oxidant and buffering agent, can also there be other materials in the electrochemical sensor.These materials comprise, for example, and viscosity intensifier and low-molecular weight polymer.Also can comprise hydrophilic substance in the sensor, as polyglycol, polyacrylic acid, dextran and as the Rohm﹠amp of philadelphia, pa; The brand name that Hass company sells is TRITON TMSurfactant or ICI Americas Inc of the Delaware State, Wilmington brand name of selling be TWEEN TMSurfactant.In a preferred embodiment, having used is Pluronic surfactant and the foam breaker that obtains from BASF.These materials can increase the filling rate of sensor, and more stable measurement is provided, and suppress evaporation in small samples.
Circuit
Conductive layer preferably is connected on the circuit by connector described herein, and this circuit can for example provide electromotive force at electrode and the ultimate current of being surveyed between the meter.The meter that is fit to can comprise one or more power supplys, be used to provide circuit, microprocessor controlled apparatus, computing machine or data storage device, display device, audible alarm unit or other devices known in the art or the assembly of control electromotive force or electric current.Meter also can be connected on computing machine or the data storage device.For example, typical meter can be one by storage battery power supply, by the hand-held device of veneer microprocessor control, and this device for example also is included in, and strip shaped electric poles connects the circuit that predetermined potential or electric current are provided between pin and the circuit as A/D converter.In this embodiment, can convert to from the simulating signal of strip shaped electric poles connector can be by the digital signal of microprocessor analysis and/or storage.Meter also can comprise as the display device of LCD and suitable connecting circuit, to show the result of test to the user.In an optional embodiment, meter can comprise special circuit, applies and signal acquisition circuit as electromotive force.The independent module that this special circuit can link to each other in conjunction with the computing machine with general-purpose computations device such as luggable computer or other types constitutes.In such an embodiment, the general-purpose computations device can be carried out control, analysis, data storage and/or Presentation Function.This embodiment can obtain meter cheaply, because the general-purpose computations device can preferably be realized many functions, so these functions just can not become the part of electrochemical measurement system cost.In these meters embodiment, any meter or general-purpose computations device can and external device (ED), connect as local computer network or Internet, so that issue test findings and system upgrade is provided to the user.
More than describe several method of the present invention and material are provided.Method of the present invention and material are easy to revise, and its method for making and equipment are easy to change.With reference to the of the present invention open or practice that provides here, those skilled in the art can be easy to realize these modifications.Therefore, the specific embodiment that the present invention can not be confined to provide here, but covered true scope and the interior all modifications and changes of main idea that embody in claims.

Claims (7)

1. electrochemical sensor, this electrochemical sensor is electrically connected with meter, this sensor comprises first dielectric base with first conductive coating, second dielectric base with second conductive coating, and the dielectric isolation layer between them, two conductive coatings are provided with mutually face-to-face with the relation that separates, the edge that wherein has first dielectric base of first conductive coating has extended beyond the edge of second dielectric base with second conductive coating, and having surpassed the edge of dielectric isolation layer, the edge that wherein has second dielectric base of second conductive coating has extended beyond the edge of dielectric isolation layer.
2. the electrochemical sensor described in claim 1, it is characterized in that, have in first dielectric base of first conductive coating, part in first dielectric base with first conductive coating that has extended beyond the dielectric isolation layer edge comprises an aperture, a feasible zone that exposes the second electrode lay, thus a surface that is electrically connected with meter formation provided by aperture.
3. the electrochemical sensor described in claim 2, it further comprises a superinsulation separation layer, this superinsulation separation layer is characterized in that between first conductive coating and second conductive coating dielectric isolation layer and superinsulation separation layer are positioned at the opposite side of aperture.
4. electrochemical sensor, this electrochemical sensor is electrically connected with meter, this sensor comprises first dielectric base with first conductive coating, second dielectric base with second conductive coating, and the dielectric isolation layer between them, two conductive coatings are provided with mutually face-to-face with the relation that separates, the edge that wherein has first dielectric base of first conductive coating has extended beyond the edge of second dielectric base with second conductive coating, and surpassed the edge of dielectric isolation layer, and first dielectric base and the dielectric isolation layer that wherein have first conductive coating comprise an aperture, a feasible zone that exposes the second electrode lay, thus a surface that is electrically connected with meter formation provided by aperture.
5. electrochemical sensor, this electrochemical sensor is electrically connected with meter, this sensor comprises first dielectric base with first conductive coating, second dielectric base with second conductive coating, and the dielectric isolation layer between them, two conductive coatings are provided with mutually face-to-face with the relation that separates, a part that wherein has first dielectric base of first conductive coating has extended beyond the edge of second dielectric base with second conductive coating, and surpassed the edge of dielectric isolation layer, and wherein having the part of first dielectric base of first conductive coating and the part of dielectric isolation layer is removed, thereby formed a slit, this slit is positioned near the edge of the edge of second dielectric base with second conductive coating and dielectric isolation layer, so that expose a zone of the second electrode lay, thereby provide a surface that is electrically connected with meter formation.
6. one kind forms the method that is electrically connected between electrochemical sensor and meter, and this method may further comprise the steps:
A) provide an electrochemical sensor, this electrochemical sensor comprises first dielectric base with first conductive coating, second dielectric base with second conductive coating, and the dielectric isolation layer between them, two conductive coatings are provided with mutually face-to-face with the relation that separates, the edge that wherein has first dielectric base of first conductive coating has extended beyond the edge of second dielectric base with second conductive coating, and having surpassed the edge of dielectric isolation layer, the edge that wherein has second dielectric base of second conductive coating has extended beyond the edge of dielectric isolation layer;
B) provide a meter, this meter comprises voussoir, and this voussoir comprises wedge shape conductive surface and following wedge shape conductive surface, and two conductive surfaces are electrically connected with meter; And
C) part of electrochemical sensor is inserted meter, like this, voussoir be inserted into the edge that extends beyond dielectric isolation layer first dielectric base with first conductive coating a part and have between the part of second dielectric base of second conductive coating, so just constitute the electrical connection between first conductive coating and the following wedge shape conductive surface, constituted the electrical connection between second conductive coating and the last wedge shape conductive surface thus.
7. method as claimed in claim 6, wherein this meter also comprises a fulcrum, it is characterized in that, voussoir can rotate on this fulcrum.
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